Hyoscyamine Sulfate, Methenamine, Methylene Blue, Phenyl Salicylate, and Sodium Phosphate, Monobasic, Monohydrate

INDICATIONS and USAGE: Urelle ® is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

DOSAGE and ADMINISTRATION: Adults – One tablet orally 4 times per day followed by liberal fluid intake. Pediatric – Dosage must be individualized by a physician for older children. Urelle® is not recommended for use in children 6 years of age or younger.

WARNINGS: If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately. Patients should be advised that urine will be colored blue when taking this medication. Do not exceed recommended dosage.

CONTRAINDICATIONS: Hypersensitivity to any of the ingredients is possible. Risk - benefit should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8402 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.